None listed
Conditions
Interventions
Intervention1: Bacopa monnieri Extract Capsules (NextBac )
: Group B
Intervention2: Group A: 300 mg Bacopa monnieri Extract Capsules (Bacognize ) Single Dose Only
Intervention3: Group B: 300 mg Bacopa
Sponsors
PHARMANZA HERBAL PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants aged between 18 and 45 years (both inclusive); 2. Female participants must have a negative urine pregnancy test prior to housing; 3. Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 07 days after completion of the study; 4. Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study. 5. Participants with a BMI between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg. 6. Participants in normal health as determined by personal medical history, clinical examination including vital signs, andclinically acceptable results of laboratory examinations (including serological tests). 7. Participants having a normal or clinically not significant 12- lead electrocardiogram (ECG) recording. 8. Participants having a normal or clinically not significant chest x-ray (P/A view). 9. A negative alcohol breath test result at housing. 10. Participant able to communicate effectively and provide written informed consent. 11. Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee. 12. Participants that can provide adequate evidence of their identity; 13. Availability of volunteers for the entire study duration. 14. Ability to fast for at least 14.00 hours and consume standard meals.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to Bacopa monnieri or related drugs or any component of this medication; 2. Incapable of understanding the informed consent information; 3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease or disorder; 4. Any treatment that could induce or inhibit the hepatic microsomal enzyme system within one month of starting the study; 5. History or presence of alcoholism or drug abuse; 6. History or presence of asthma, urticaria, or other allergic reactions; 7. History or presence of gastric and/or duodenal ulceration; 8. History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion; 9. History or presence of cancer; 10. Difficulty with donating blood; 11. Use of any prescribed medication (including herbal remedies)during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week prior to study initiation and throughout the study; 12. Use of medications such as tricyclic antidepressants, benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study; 13. Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study; 14. Participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study; 15. Participant consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeine containing sodas, colas, etc.) and grapefruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study; 16. Major illness during the 90 days before screening; 17. Participation in a drug research study within 90 days of screening; 18. Donation of blood within 90 days of screening; 19. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL; 20. History or presence of easy bruising or bleeding; 21. Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study; 22. Male and female volunteers unwilling to employ appropriate contraceptive measures to ensure that their partner will not get pregnant during the study till 07 days after the completion of the study; 23. Male volunteers willing to donate sperm during the study till 07 days after the completion of the study; 24. Females of childbearing potential with any one of the following reported and documented on the medical history: i. Postmenopausal with spontaneous amenorrhea for at least one year, or ii. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or iii. Total hysterectomy and an absence of bleeding for at least 3 months. iv. Female volunteers who have used implanted or injected h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Pharmacokinetics parameters like Cmax, Tmax, AUC0-t, AUC0-infinity, t1/2, and Kel from the concentration Vs. time data.Timepoint: [within 45 min before IP administration] and post-dose at 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 9.00, 12.00, and 24.00 hrs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. vital signs. 2. Chest X-ray ((P/A view) 3. Clinical examination, ECGs, & clinical laboratory testing (hematology, blood chemistry, & urinalysis) 4. Adverse events, serious adverse events 5. Tolerability of the investigational productTimepoint: 1. Screening & Day 1 (pre-dose, & post-dose) 2. At Screening 3. At Screening & Day 2 4. From Screening to End of the Study 5. At Day 1 & Day 2 | — |
Countries
India
Contacts
Public ContactRaj Bhatt
PHARMANZA HERBAL PVT. LTD.,
Outcome results
None listed